Multi-fire stapling systems

ABSTRACT

A staple housing includes an array of staples each in a staple delivery position or “ready position” ready to be fired into target tissue. A staple driver is advanceable to drive the ready position staples from the staple head into the tissue using staple pushers. During use, the staples in the ready positions are simultaneously fired into the target tissue using the staple pushers, forming an array of staples in the target tissue. After the array has been fired, one or more feed mechanisms within the staple housing advance a second group of staples from one or more staple storage locations into the ready positions in preparation for firing of the second group of staples.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.13/089,216, filed Apr. 18, 2011 (now U.S. Pat. No. 8,747,421), which isa divisional of U.S. patent application Ser. No. 12/268,404, filed onNov. 10, 2008 (now U.S. Pat. No. 7,934,631), which are incorporatedherein by reference in their entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to the field of medicalstaplers. More specifically, the present invention relates to the fieldof self-reloading staplers.

BACKGROUND

Surgical staplers have been in clinical use for many years. They havebecome a standard tool used by surgeons in procedures requiring tissueapposition, ligation, resection and/or anastomosis. Staplers reduceoverall procedure time by eliminating the need for the time-consumingplacement of sutures. Staplers can reduce blood loss in certainprocedures involving resection of tissue to be stapled, by allowingtissue cutting/resection to be performed after the tissue is compressedand stapled. For example, a pair of staple rows is first formed, andthen the tissue is cut along a line between the staple rows.

Surgical staplers are configured to fire the multiple staples of astaple array (e.g. a linear array such as a staple line, a circulararray etc.) in a single shot. Early staplers comprised reusable handlesand disposable staple cartridge loads holding a single staple array.Subsequent staplers used disposable handles and disposable cartridgeloads. During clinical use of the prior art staplers, spent cartridgesmust be removed from the handles and replaced with fresh cartridges.Thus, a stapler carrying a single charge of staples is fired into thetissue and then removed from the patient. The spent cartridge is ejectedand a new cartridge is loaded for the next staple line. The stapler isreintroduced into the body and the process is repeated for the next lineor array of staples to be applied to tissue. The need for constantreloading of the stapler is particularly time consuming in transoralnatural orifice surgeries, as the time required for repositioning thestapler head after removing the device from the stomach or other bodycavity is not insignificant. Moreover, the requirement for multiplestaple cartridges per procedure adds to the overall cost of theprocedure.

Disclosed herein is a staple housing or cartridge preloaded with atleast two sets of staples such that at least two staple arrays can beapplied to tissue before the stapler must be actively reloaded. Eachstaple set contains two or more staples, with the staple sets arrangedto form a staple array of at least two (but preferably more) staples ina linear or non-linear array. Each staple housing or cartridge ispreloaded with at least two staple sets, but three, four, or morestaples sets may instead be provided in the staple housing to limit thenumber of times the staple housing must be reloaded or equipped with anew cartridge during the course of a procedure.

The disclosed multi-fire staple housings and cartridges are suitable foruse in any form of medical stapling procedure, including endoscopic,laparoscopic, open surgical and natural orifice procedures which utilizenatural body orifices for surgery to reduce the invasiveness of theseprocedures. Natural orifices include, but are not limited to theesophagus, anus and vagina.

The disclosed multi-fire staple housings and cartridges are particularlybeneficial for use within the stomach, such as during stomachpartitioning procedures in which the stomach is partitioned from theinside by connecting tissue within the stomach (see commonly ownedapplication Ser. No. 12/119,329, filed May 12, 2008, entitled DEVICESAND METHODS FOR STOMACH PARTITIONING), or for forming tissue plicationswithin the stomach for use in retaining stomach implants (see commonlyowned application Ser. No. 12/175,242, filed Jul. 17, 2008, entitledENDOSCOPIC IMPLANT SYSTEM AND METHOD and application Ser. No.12/050,169, filed Mar. 18, 2008, entitled ENDOSCOPIC STAPLING DEVICESANT) METHODS).

Multi-fire staple housings or cartridges may be incorporated intomulti-function devices, such as those that perform both stapling andcutting (e.g. end to end anastomosis devices, or linear stapling/cuttingdevices), and/or those that can both acquire and staple tissue. Thestaple housing is a removable/replaceable cartridge or magazine and/orit may be refillable by inserting additional staples into it. In otherembodiments, the staple holder may be neither replaceable norrefillable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a first embodiment of a multi-firestapler head, showing the jaws in the open position and the stapledriver in the pre-firing position.

FIG. 1B is similar to FIG. 1A and shows the jaws in the closed positionand the staple driver in the pre-firing position.

FIG. 1C is similar to FIG. 1A and shows the jaws in the closed positionand the staple driver in the firing position.

FIG. 2 is a plan view of the stapler housing, with the face plateremoved.

FIG. 3A is a perspective view showing a longitudinal cross-section ofthe staple housing with the back plate removed.

FIG. 3B is a perspective view showing a lateral cross-section of thestaple housing with the back plate removed.

FIG. 4 is a perspective view of the staple advancing plate and one ofthe two springs provided on the plate.

FIG. 5A is similar to FIG. 2 but shows an alternate type of spring inthe feed mechanism.

FIG. 5B shows a single cell of the embodiment of FIG. 5A, with thespring replaced by an elastomeric member.

FIG. 6 shows a cross-section view of a portion of the staple housing anda portion of the staple driver in the region of a single one of thecells.

FIGS. 7A-7C are a sequence of side elevation views schematicallyillustrating movement of an alternative staple driver to drive staplesfrom a staple housing into tissue.

FIGS. 8A-8E are a sequence of side elevation views schematicallyillustrating movement of a second alternative staple driver to drivestaples from a staple housing into tissue.

FIG. 9A shows a plan view of an alternate staple housing with the backplate removed.

FIGS. 9B-9E are a sequence of side elevation views schematicallyillustrating movement of a staple driver to drive staples from thestaple housing of FIG. 9A into tissue.

FIGS. 10A through 10C are a sequence of perspective views schematicallyshowing driving of a staple from a ready position towards tissue to bestapled, and subsequent reloading of the next staple from the stack intothe ready position.

FIGS. 11 and 12 are perspective views illustrating one method of forminga staple stack for use in the stapler of FIG. 1A.

FIGS. 13 through 15 are a sequence of steps illustrating use of thestapler of FIG. 1A, in which

FIG. 13 is a side elevation view showing the jaws closed and the stapledriver in the retracted position,

FIG. 14 is a side elevation view showing the jaws opened and the stapledriver in the retracted position, and

FIG. 15 is a side elevation view showing the jaws closed and the staplerdriver extending through the staple housing to drive an array ofstaples.

FIG. 16 is a plan view of a second embodiment of a stapler employing analternate multi-fire staple housing.

FIG. 17 is an exploded view of the staple cartridge of the FIG. 16stapler.

FIG. 18 is another exploded view of the staple cartridge of FIG. 17, inwhich the staples, staple advancing elements, and staple pusher are notshown for clarity.

FIG. 19 is a perspective view of the staple cartridge of FIG. 17 in apartially assembled state, with staples and staple advancing elementsloaded, but with the front housing separated to permit viewing of thestaples and staple advancing elements. The compression band and staplepusher are not shown.

FIG. 20 is a perspective view of the staple pusher for the staplecartridge of FIG. 17.

FIG. 21A is a perspective view of the staple cartridge of FIG. 17, withthe staple pusher in the retracted position.

FIG. 21B is similar to FIG. 21A and shows the staple pusher in thestaple driving position to drive staples from the staple cartridge.

FIG. 22 is a top plan view of the staple cartridge of FIG. 17, showingin hidden lines the staple stacks and staple advancing elements.

FIGS. 23A through 23C are a sequence of cross-section views of thecartridge showing driving of staples from a ready position towardstissue to be stapled, and subsequent reloading of the next staples fromthe staple stacks into the ready position.

FIG. 24 is a perspective view of an alternative embodiment of a staplehead, in which a spent cartridge is positioned in the background, asecond cartridge is within the staple housing, and a third cartridge isawaiting advancement into the staple housing to replace the secondcartridge.

FIG. 25 is a perspective view illustrating a first cartridge advancinginto the staple housing and a second cartridge coupled to the firstcartridge.

FIGS. 26A through 26E are a sequence of drawings illustrating the stepsof driving staples from a cartridge, and the advancement of a secondcartridge into the staple housing.

DETAILED DESCRIPTION

FIG. 1A generally shows a stapler 8 employing a multi-fire staple head10. Staple head 10 includes a staple housing 12 and a correspondinganvil 14 carried by opposed jaw members 16 a, 16 b on the distal portionof an elongate shaft 18. As will be evident from the description thatfollows, the staple housing 12 has an array of staples each in a stapledelivery location or “ready position” ready to be fired into targettissue. A staple driver 20 is positioned for advancement from theposition shown in FIG. 1B to the position shown in FIG. 1C so as todrive the ready-position staples from the staple head 12 into the tissueusing staple pushers 22. During use, the staples in the ready positionsare fired into the target tissue using the staple pushers 22. After thearray has been fired, feed mechanisms within the staple housing advancea second array of staples from one or more staple storage locations intothe ready positions in preparation for firing of the second array.

Referring again to FIG. 1A, staple head 12 includes a face plate 24having a number of openings 26 through which the staples exit the staplehead 12 during stapling. The openings 26 are thus arranged in thepattern of the desired staple array. An internal feed mechanism withinthe staple housing 12 functions to feed staples from stacks of staplesinto ready positions, which are aligned with the openings 26. In theillustrated embodiments, separate feed mechanisms are used to move eachstaple of the array into its corresponding ready position. Otherembodiments, however, may use feed mechanisms capable of feeding staplesinto multiple ready positions. FIG. 2 shows a plan view of the staplehousing 12 in which the face plate 24 has been removed to reveal thefeed mechanisms used to feed staples into ready positions. As shown, thestaple housing 12 includes a plurality of cells 28, the number of whichcorresponds to the number of staples in the array. Any number of shapesmay be used for the cells 28, although in the illustrated embodiment,each cell 28 includes an intermediate section 29 a and narrower endsections 29 b.

Each cell 28 contains a collection or stack 30 of staples disposed inthe intermediate section 29 a. One of the staples 30 a is in a readyposition 31 aligned with the corresponding opening 26 (FIG. 1A) of theoverlying faceplate 24. In one of the end sections 29 b is a feedmechanism which includes at least one spring 32 and a plate 34. Asshown, one end of the spring 32 contacts a wall in the cell 28, and theother end contacts one face of the plate 34. The opposite face of theplate 34 is in contact with staple stack 30. The spring force againstthe plate 34 biases the end-most staple 30 a in the ready position 31,in contact with the walls 36. When a staple is advanced from the readyposition into tissue, this spring force advances the stack's next stapleinto the ready position 31.

Various types of springs may be used in the feed mechanism. In theembodiment illustrated in FIGS. 2-3B, a pair of compression springs 32is used within each cell 28. As shown in FIG. 4, each spring 32 may besupported on one end by a protrusion or button 38 on the plate 34.

In alternate spring arrangements, the compression springs are replacedby one or more leaf springs 32 a as shown in FIG. 5A and/or by one ormore elastomeric spring elements 32 b as shown in FIG. 5B. It shouldalso be noted that FIG. 5A illustrates the staple stacks and feedmechanisms in a staple housing having a channel 35 through which acutting blade can pass for tissue resection subsequent to stapling.

FIG. 6 is a cross-section view of a single cell and surrounding regionof the staple housing 12. This figure illustrates that a back plate 48is positioned on the opposite side of the staple housing 12 from theface plate 24, and includes openings 50 (only one of which is shown)aligned with the corresponding openings 26 (one shown) on the face plate24. The openings 50 are positioned to permit a staple pusher to passthrough them into the staple housing 12 to drive staples out theopenings 26 in the face plate 24.

Features used to push staples from the ready position through the tissuewill next be described. Referring to FIG. 1A, staple driver 20 includesa plurality of staple pushers 22 extending from a plate. A linkage 40couples the staple driver 20 to the stapler head 12, with the staplepushers 22 aligned with openings 50 in the back plate 48 (FIG. 6).

Linkage 40 has a first link 42 having a first end pivotally coupled tothe plate of the staple pusher 22 and a second end connected to a pullcable 44. Pull cable 44 extends through a cable housing 45 to a handleon the shaft. A second link 46 is pivotably coupled at one end to anintermediate section of the first link 42, and it is pivotably coupledat its other end to the staple housing 12. The linkage is configuredsuch that application of tension to the pull cable 44 pivots the links42, 46 from the position shown in FIG. 1B to that shown in FIG. 1C, thusdriving the staple driver 20 towards the staple housing, causing staplepushers 22 to pass into the staple housing 12 and to drive the staplesin the manner illustrated in FIG. 6.

Various other methods may be used to advance a staple pusher to drive astaple from the staple housing. Some alternate methods, each of whichuses a translating staple driver, are shown schematically in FIGS. 7Athrough 9E.

FIGS. 7A-7C illustrate a linear arrangement of staples 30 a being drivenfrom a staple housing 12 (which could be a cartridge or magazine) with adriver 52 moveable in a direction parallel to the back span of thestaples. This motion could be generated with hydraulic pistons 51 asshown, or with pull cables, linkages, rotary input, as well as othermeans. Pushers 53 are positioned in contact with the back spans of thestaples. The driver 52 includes a plurality of wedge elements 54positioned such that as the driver is advanced, the sloped edges of thewedge elements 54 contact the pushers 53, causing the pushers to drivethe staples 30 a from their corresponding chambers in the staple housing(FIGS. 7B and 7C. In a modification of this embodiment, the pusher 53 isprovided with a single wedge element used to sequentially drive staplessimilar to the manner shown in FIGS. 8A-9E below.

In the example pictured in FIGS. 7A-7C, two staples 30 a are driven atthe same time, but any number of staples could be driven similarly.Multiple drivers 52 and corresponding rows of staples can exist in thesame tool. Once the driver 52 has fully driven the staples from thehousing, it is returned to the home position. The return could beactive, with operator input, as in the case of a separate hydrauliccircuit, or cable to return the mechanism, or passive, with the driverreturning on its own with forces supplied by a spring or springs whichwere compressed during actuation. In the illustrated embodiment, springs55 compressed by the pushers 53 during staple firing return the pushers53 to their original position in the housing after the driver has movedout of their path. A feed mechanism within the housing 12 advancesanother round of staples into the ready position for the next actuationas disclosed elsewhere in this application.

Another embodiment illustrated in FIGS. 8A-8E is similar to the FIG.7A-7C embodiment, but it employs a bi-directional staple deploymentscheme. As shown, driver 52 a includes a wedge element 54 a having twosloped edges. During movement of the driver 52 a in a first direction, afirst set of staples 30 a is sequentially driven into the tissue (FIGS.8B and 8C). Once the first set of staples has been fired, another stapleset can be brought into the ready positions (in the return path of thedriver), such that the return motion of the wedge element 54 a candeploy the second set into the tissue. In a modification to the FIG. 8Aembodiment, a plurality of bi-directional wedge elements are positionedsimilar to the positions of the wedge elements in the FIG. 7Aembodiment, allowing for simultaneous advancement using the multiplewedge elements on the driver. In this variation, movement of the driverin a first direction will drive a first set of staples and then movementof the driver in the opposite direction will drive the second set ofstaples fed into the ready positions vacated by the first staples.

In modifications to the embodiments of FIGS. 7A and 8A, the staples maybe oriented in the staple housing such that the staple back spans arerotated 90 degrees from the position shown in FIGS. 7A and 8A (i.e. thestaples are turned such that the back span extends into and out of thepage in FIGS. 7A and 8A). One configuration using this design is shownin FIGS. 9A-9E. FIG. 9A shows the housing 12 a with the back plateremoved and shows only one row of drivers and staples for simplicity. Inpractice, each row would be filled with staples and each row could bedriven into the anvil separately, or in groups, depending on the desiredactuation scheme. Additionally, the staples could be arranged with theback spans at angles other than 90 degrees to the driver.

Referring to FIGS. 9B-9E, driver 52 b includes a wedge 54 b. The stapleback spans are transverse to the direction of motion of the driver 52 b.In FIG. 9B, the wedge is at its start position. To drive the staples,driver is pulled to the right by a cable, or other flexible elementactuated by any means providing appropriate force. As the driver 52 btravels, it forces the sloped caps 53 b positioned above each the staplein a downward direction. The caps 53 b drive the staples through thetissue and towards the anvil (not shown). As with the previousembodiments, a spring or other element may be used to return the caps tothe original position.

FIGS. 10A through 10C schematically illustrate operation of the staplepusher and automatic feed mechanism to fire a staple from the readyposition and to then replace the fired staple in the ready position withthe next staple in the stack. Referring to FIG. 10A, prior to staplefiring, staple 30 a is biased in the ready position due to the action ofthe spring force F imparted against the plate 34 by the spring (notshown in FIG. 10A). Staple pusher 22 is advanced as discussed above tofire the staple. FIG. 10B. Due to the constant spring force F againstthe plate 34, as soon as the staple 30 a leaves the ready position, itis replaced in the ready position by the next staple 30 b in the stack30. FIG. 10C. This automatic reloading of staples into the readyposition repeats itself as each staple 30 a-30 n in the cell is fired.After all staples 30 a-30 n have been fired, the staple housing may bereloaded with a new charge of staples if additional stapling is needed.

The stapler housings and staple cartridges disclosed herein may be usedwith any suitable staples or staple stacks. Staple stacks may be formedusing a sheet of flat material 58 as shown in FIG. 11. Longitudinalscore lines 60 are formed on one side of the sheet 58, and the ends 62of the sheet are chamfered to create what will be the tips of the staplelegs. The sheet 58 is bent into the shape shown in FIG. 12, with thescore lines 60 serving as the dividing lines between what will becomeindividual staples. With this arrangement, each time the staple pusheris driven, it causes the endmost staple to be sheared from the sheet offlat material and driven into the tissue.

Use of the stapler 10 will next be described. Prior to use, staplestacks 30 are loaded into the cells of the staple housing 12. With thejaws 16 a, 16 b in the closed position as in FIG. 13, the staple head 10is advanced to the location of the tissue to be stapled. Next, a controlelement on the handle of the stapler shaft is manipulated to open thejaws to the position shown in FIG. 14. Various configurations known tothose skilled in the art may be used to open and close the jaws. Theillustrated embodiment employs a linkage 64 coupled to the jaws 16 a, 16b. Linkage 64 is actuated using a piston 66, which is moved distallyusing hydraulic or mechanical means to expand the linkage for openingthe jaws (FIG. 14) and which is moved proximally to collapse the linkageand close the jaws (FIG. 13).

With the jaws 16 a, 16 b opened, the tissue to be stapled is positionedbetween the staple housing 12 and anvil 14. The stapler may be equippedwith integrated tissue acquisition devices useful for this purpose.Suitable tissue acquisition devices are described in the followingcommonly owned applications: application Ser. No. 12/119,329, filed May12, 2008, entitled DEVICES AND METHODS FOR STOMACH PARTITIONING, andapplication Ser. No. 12/050,169, filed Mar. 18, 2008, entitledENDOSCOPIC STAPLING DEVICES AND METHODS, and application Ser. No.12/268,216, entitled TISSUE ACQUISITION DEVICES AND METHODS, filed onsame date herewith. In that application, tissue is acquired into avacuum head using a vacuum source, and then the acquired tissue isretained (e.g. for tissue positioning, manipulation) by a grasper.Alternatively, separate instruments may be used to position tissuebetween the cartridge and anvil.

When an area of the stomach wall is drawn inwardly (bringing a two-layer“pinch” or fold of tissue toward the stomach exterior), correspondingregions of serosal tissue on the exterior of the stomach are positionedfacing one another. According to a preferred method disclosed herein,two or more such areas or pinches of the stomach wall areengaged/grasped and drawn inwardly using instruments passed into thestomach via the mouth. The two or more pinches of tissue are held incomplete or partial alignment with one another as staples or otherfasteners are driven through the pinches, thus forming a four-layerplication. Over time, adhesions formed between the opposed serosallayers create strong bonds that can facilitate retention of theplication over extended durations, despite the forces imparted on themby stomach movement. A cut or cutout may be formed in the plicationduring or separate from the stapling step to promote edge-to-edgehealing effects that will enhance tissue knitting/adhesion and willultimately contribute to the durability of the plication, despite thefact that mucosal tissue of one tissue pinch is positioned in appositionwith the mucosal tissue of the other tissue pinch.

One or more such plications may be formed for a variety of purposes. Forexample, plications may be used to induce weight loss by creating abarrier or narrowing within the stomach that will restrict the flow offood from the proximal stomach towards the distal stomach. For example,a partition or barrier may be oriented to extend across the stomach,leaving only a narrow exit orifice through which food can flow from theproximal stomach to the distal stomach, or a similar antral barrier maybe formed that will slow stomach emptying of stomach contents into thepylorus. In other cases, partitions or plications may be used to form aproximal pouch in the stomach or to reduce stomach volume to causesensations of fullness after a patient eats relatively small quantities.

Coupled to or provided with the stapler are one or more, preferably two,three or more, tissue acquisition devices, which will also be referredto as “engagers” or “graspers” which are designed to engage tissue anddraw the tissue into position between the stapler anvil and cartridge.In embodiments, the graspers are positioned to pass from one side of the“window” bounded by the stapler arms, through the window, and used tograsp tissue on the opposite side of the window. These graspers are thenwithdrawn back through the window to draw the grasped tissue between thecartridge and anvil. In other embodiments, the arms can engage tissueand draw it between the cartridge and anvil without necessarily passingthrough the window. Such embodiments include the arms oriented angularlyrelative to one another when viewed along the longitudinal axis of thedevice shaft.

The graspers can be simple alligator or forceps type graspers, vacuumchambers, corkscrews which can be traditional corkscrews or gear-drivenperpendicular cork-screws, hooks, or any combination thereof, such as acorkscrew in combination with a vacuum chamber.

The term “grasper” is used to refer generally to any type of tool thatcan be used to engage or acquire tissue via any means (grasping,hooking, penetration, suction, adhesion, etc.) so the acquired tissuecan be positioned between the staple holder and anvil. Similarly, eventhough some of the disclosed graspers do not physically “pinch” tissue,the term “pinch of tissue” may be used in this disclosure to refer to afold, area, or tab of tissue acquired using a grasper for positioning ofthe that fold, area, or tab between the staple holder and the anvil.

Plugs/pledgets within the cut holes may be used to hold two or moretwo-layer plications together. For example, rather than joining twopinches of tissue as disclosed above to form a four-layer plication, thestapler may be used to separately staple and cut each pinch, forming aplurality of two-layer plications. Afterwards, pairs (or larger groups)of the two-layer plications may be joined together to position the cutholes into alignment, and the plugs/pledgets may be inserted through thealigned holes to retain the plications. Plugs/pledgets passed throughthe hole in one or more two- or four-layer plication can function asrestrictive devices themselves, and may be used to restrict flow of foodtowards the distal stomach.

Once tissue is between the cartridge and anvil, the jaws are againclosed (FIG. 13) to close the staple housing and anvil against thetissue, thereby compressing the tissue in preparation for stapling. Thecable 44 (FIG. 1A) is actuated to drive the staple driver 20 towards thestaple housing 12, thus driving the staple pushers 22 into the staplehousing 12 (FIG. 15) to fire the array of staples through the tissue. Asis typical with staplers, the free legs of the staples fold againstcorresponding recesses (not shown) on the anvil surface.

When tension is released from the cable 44, springs (not shown) forcethe staple driver 20 back into the retracted position shown in FIG. 13.Once the staple driver 20 withdraws from the staple housing, a newstaple moves into the ready position in each cell (as described inconnection with FIGS. 10A through 10C), immediately readying the staplerfor deployment of a second staple array.

FIG. 16 is a side view of an alternate embodiment of a multi-firestapler 110. Stapler 110 includes a stapler head 112 mounted to anelongate shaft 114. A staple housing, which may be a replaceable staplecartridge 116, and an anvil 118 are positioned on the stapler head 112.The stapler head 112 is equipped with linkages operable to decrease thedistance between the cartridge and anvil for tissue compression andstapling. These features, as well as others (e.g. hydraulic and pistonarrangement, cutting features, etc.) suitable for inclusion in thestapler 110, are disclosed in commonly owned application Ser. No.12/050,169, filed Mar. 18, 2008, entitled ENDOSCOPIC STAPLING DEVICESAND METHODS, which is incorporated herein by reference.

Like the staple housing of the first embodiment, cartridge 116 is amulti-fire unit configured to simultaneously fire an array of staples,and to automatically reload a subsequent array of staples ones the firstarray has been discharged. The staples in the array can be arranged in avariety of patterns, including but not limited to the square patternshown in connection with the FIG. 16 embodiment.

In embodiments, tissue is drawn inwardly into a vacuum chamber, althoughtissue may be drawn inwardly using other components (e.g. graspers) thatdo not involve the use of a vacuum. When a portion of the interiorstomach wall is drawn inwardly, sections of serosal tissue on theexterior of the stomach are positioned facing one another. The disclosedfastener applying device allows the opposed section of tissue to bemoved into contact with one another, and delivers fasteners that willhold the tissue sections together until at least such time as serosalbonds form between them.

The system may include a stapler having a stapler head positioned on adistal portion of a shaft. A handle on the shaft controls articulationof the stapler head and actuation of the tissue acquisition, tissuecompression, and stapling functions of the stapler head. Vacuum andfluid sources are fluidly coupled to the handle for use in tissueacquisition, compression and stapling as discussed below. The vacuumsource may be the “house vacuum” accessible through a coupling on thewall of the operating room, or an auxiliary suction pump. The staplermay include a switch allowing the user to control airflow between thevacuum source and stapler.

Features of the cartridge 116 will first be described with reference tothe exploded views shown in FIGS. 17 and 18. The cartridge includes afront housing 120, middle housing 122 and a rear housing 124. The fronthousing 120 is positioned at the distal end of the cartridge andincludes a plate 126 that contacts the tissue to be stapled duringstapling. Spaced apart members 128 extend longitudinally from the plate126 in a proximal direction. Each of the members 128 includes acircumferential channel 130. The plate 126 includes a central cutout 132proportioned to receive middle housing 122.

Rear housing 124 has a plate 134 with a cutout 136 proportioned toreceive the middle housing 122. Spaced apart members 138 extendlongitudinally from the plate 134 in a distal direction. Members 138have circumferential channels 140.

Middle housing 122 includes longitudinal sidewalls 142 proportioned toallow the middle housing 122 to slide into the central cutouts 132, 136of the front and rear housings. Each of the sidewalls 142 has alongitudinally extending first channel 144 centrally positioned on thesidewall 142, and a longitudinally extending second channel 146centrally positioned within the first channel 144.

As shown in FIG. 21A, in the assembled cartridge, the middle housing 122extends between the cutouts of the front and rear housings. Thelongitudinally extending members 128 of the front housing 120 aredisposed between the longitudinally extending members 138 of the rearhousing such that the channels 130 of the walls 128 are aligned with thechannels 140 of the walls 138, forming a continuous circumferentialchannel extending around the cartridge 116. As discussed in greaterdetail below, a compression band 152 (also see FIG. 18) is positioned inthis circumferential channel.

When housings 120, 122, 124 are assembled, spaces between their variouswalls form chambers within which staples are positioned during use.Referring to FIGS. 21A and 21B, rectangular U-shaped chambers 148 aredisposed between each of the longitudinally extending members 128 andits neighboring members 138. FIGS. 17 and 22 illustrate that a stack orcollection of staples 30 is disposed in each of the chambers. A total offour such chambers 148 are shown, corresponding to four stacks ofstaples for the illustrated embodiment.

Each staple is positioned in its corresponding chamber with its legsdisposed in the longitudinally extending branch of the chamber, and withthe cross-member or back span of the staple in the laterally extendingportion of the chamber. Each of the chambers 148 also houses rectangularU-shaped staple advancing element 150 adjacent to the radially outermostone of the staples 30.

Compression band 152 is disposed within the circumferential channelformed by the aligned channels 130, 140. The inner wall of thecompression band is in contact with the longitudinally extending legs ofeach of staple advancing elements 150 in the cartridge. The radiallyinward spring forces of the compression band bias the staple advancingelements 150, and thus all of the staples, in radially inwarddirections.

Referring again to FIG. 22, the longitudinal channels 144, 146 of themiddle housing 122 form a chamber 154 with the walls bordering thecutouts in the front and rear housings 120, 124. The innermost staple 30a in each stack is biased into the chamber 154 by the radially inwardforces of the compression band 152. A staple in the chamber 154 is inthe ready position, ready for advancement from the cartridge intoadjacent tissue.

FIG. 19 shows the front and rear housings aligned for insertion of theelements 128 of the front housing between the elements 138 of the rearhousing. This figure best shows the positions of the ready positionstaple 30 a, the remaining staples 30 b-n, and the staple advancingelement 150 for a given stack. As shown, the ready position staple 30 ais biased against the wall of the middle housing 122 lining the firstchannel 144. The compression band 152 is removed for clarity.

A staple pusher assembly 156 (FIGS. 17 and 20) is provided for drivingstaples that are in the ready position from the cartridge into thetissue. Staple pusher assembly 156 includes pusher elements 158 slidablein a distal direction within corresponding ones of the chambers 154.Each pusher element has a plate 160 that slides through a correspondingone of the channels 144 of the middle housing (FIG. 19), to drive theready position staple 30 a biased into that channel. A rib 162 on theinwardly facing surface of the plate 160 slides through the associatedchannel 146 to maintain proper alignment of the pusher assembly 156 withthe middle housing. Pusher assembly 156 may be advanceable by means of ahydraulically activated piston as described in commonly ownedapplication Ser. No. 12/050,169, filed Mar. 18, 2008, entitledENDOSCOPIC STAPLING DEVICES AND METHODS, or by other means.

FIGS. 23A through 23C are a sequence of cross-section views illustratingstaple firing and subsequent reloading of the staple positions inpreparation for an additional firing. FIG. 23A shows the cartridge priorto the firing of the first array of staples. As shown, the pusherassembly 156 is in the frilly retracted position. The most radiallyinwardly positioned staples 30 a of each staple stack 30 are disposed inthe ready position in chamber 154. The second, third etc. staples 30 b-nof each stack are positioned in the chamber 148. In the FIG. 23A view,only the cross-pieces of the staples 30 b-n are visible (in transversecross-section) along with the corresponding portion of the U-shapedchamber 148. FIG. 23B shows the position of the pusher assembly 156 asit completes the process of pushing staples 30 a from the cartridge. Theanvil, against which the legs of each staple fold, is not shown in FIGS.23A-C.

The pusher assembly is next retracted as shown in FIG. 23C The radiallyinward forces of the compression band 152 against the staple advancingelement 150 push the next staple in each stack into the ready position(i.e. in channel 144) vacated by the first staples to be driven. Thestapler head may be repositioned to a second tissue area to be stapled,at which time the pusher assembly is again advanced to drive the secondarray of staples into the tissue. The process is repeated until thedesired number of arrays has been applied to tissue, and/or until thestaple sets have been exhausted. If additional staples are needed afterthe cartridge has been emptied of all staples, the stapler head iswithdrawn from the patient, and the cartridge may be removed from thestapler and replaced with one filled with staples. Alternatively, theexisting cartridge may be refilled by removing the compression band andthe staple advancing elements, inserting staples in the chamber 154, andthen replacing the staple advancing element and the compression band.

The disclose multi-fire staple housings are useful in carrying out anumber of procedures, including but not limited to stomach partitioningand/or the formation of stomach wall plications for use in retainingimplants.

For example, the disclosed multi-fire housings may be employed in astomach wall partitioning system. When an area of the stomach wall isdrawn inwardly (bringing a two-layer “pinch” or fold of tissue towardthe stomach exterior), corresponding regions of serosal tissue on theexterior of the stomach are positioned facing one another. In stomachwall partitioning methods disclosed in commonly owned application Ser.No. 12/119,329, filed May 12, 2008, entitled DEVICES AND METHODS FORSTOMACH PARTITIONING, two or more such areas or pinches of the stomachwall are engaged/grasped and drawn inwardly using instruments passedinto the stomach via the mouth. The two or more pinches of tissue areheld in complete or partial alignment with one another as staples orother fasteners are driven through the pinches, thus forming afour-layer tissue plication.

Multiple plications of this type may be used to induce weight loss bycreating a barrier or narrowing within the stomach that will restrictthe flow of food from the proximal stomach towards the distal stomachand/or that will effectively reduce stomach volume to cause sensationsof fullness after a patient eats relatively small quantities. Apartition formed using plications might also be used as a treatment forGERD to create a shield between the stomach and esophagus that willminimize reflux.

Commonly owned application Ser. No. 12/175,242, filed Jul. 17, 2008,entitled ENDOSCOPIC IMPLANT SYSTEM AND METHOD and application Ser. No.12/050,169, filed Mar. 18, 2008, entitled ENDOSCOPIC STAPLING DEVICESAND METHODS describe formation of plications by drawing a pinch ofstomach wall tissue inwardly to form a tissue fold, and by then applyingstaple arrays or other fastening means to the tissue fold to retain theplication. Holes may be formed in the plications for receiving implantsor anchors to which additional implants will be coupled.

The disclosed multi-fire staple housing will greatly facilitate thesetypes of procedures by allowing serial formation of each of the requiredplications without necessitating removal of the stapler head from thestomach after formation of each plication. In other words, after astaple array is applied to tissue to create a plication, the staple headmay be immediately repositioned and used to create second and subsequentplications, all without the need to remove the stapler head from thebody for reloading or replacement with a fresh stapler. Thus, a stomachwall partition or a collection of plications may be formed in less timethan was previously possible.

In addition to the staple arrangements disclosed above, alternativearrangements are suitable and can be used with feed mechanisms of thetype disclosed above.

In one alternate staple arrangement, staples are formed into chains suchthat the legs are adjacent and the back spans do not touch. Thearrangement would look like this: UUUUUUUU, although overlap of thestaple elements is also possible. As one staple in the chain is drivenfrom a ready position in the staple housing, and the driving memberretracted, the next staple is moved into the ready position, with thefeed motion primarily along the axis of the back span of the staple.Staples may be fired singly, or in multiples at the same time or atalternating times with one group (or single staple) firing while anothergroup (or single staple) is reloading.

In a radial or “revolver” type staple arrangement, staples are arrangedlike spokes of a wheel, housed within a wheel, or on a belt, with thestaple legs, and direction of driving generally parallel to the axis ofthe wheel (like the bullets in the chamber of a revolver). As anexample, 3 of the 12 staples (either equally spaced about the ring ornot) could be advanced, then the driving member is retracted and eitherthe driving member indexed to the next three staples, or the staplemagazine is indexed such that the next three staples are aligned withthe driver. This motion could continue for 4 total firings of 3 stapleseach. In a modified, ferris wheel type arrangement, the staples areoriented with the staple legs perpendicular to the axis of the wheel, orin a non-circular belt. In this case, the driver would drive staplestoward the outside from the inside, or toward the inside from theoutside of the wheel or belt.

Other embodiments use flat nested arrangements of staples. For example,a low profile way of storing the staples would be to lay them flat oneach other with each one slightly in front of the previous one, likedominoes after they have fallen. In this case, a method of tilting upthe staple to be driven would be used. Double forming without tiltingwould also make this possible. In this instance, staples would be pushedforward and bent down, then crushed to the traditional B shape.

In another arrangement, the array or magazine of staples consists of achain of groups of staples. The staples are housed in a link of thechain Which is designed to interface with the driving member. When alink of the chain, with one to 5 or more staples is advanced to thedriver, those staples may be driven. Upon retraction of the driver, thechain is advanced and the spent link is pushed beyond the driving zoneand a new link is advanced into the driving zone. The spent links couldmove to a containment area, or proceed out of the device. Similarly, theloaded links could be housed in a containment area, or extend beyond theenvelope of the device. If the material of the chain in this example, orany mentioned elsewhere in this description, were biocompatible, orbioabsorbable, the links of the chain could be discarded in the lumen orincorporated into the staple line such that no, or less, spent chainmaterial required post-firing management.

One embodiment of a stapler employing this concept will next bedescribed. FIG. 24 illustrates a stapler head 210 including a housing212 and an anvil 214. Three staple cartridges 216 a-c are shown.Cartridge 216 a, shown coupled to the housing 212 and facing anvil 214,contains a plurality of staples and is position for staple delivery,i.e. to receive a driver that will fire the staples from the cartridgeinto tissue disposed between the cartridge and anvil. Cartridge 216 b,which has already been fired, is in the background. Another cartridge216 b is in the foreground, waiting to be advanced into position betweenthe cartridge and anvil for reloading of the stapler. The cartridges 216a-c are flexibly linked together.

FIG. 25 shows a close-up view of the cartridge 216 a prior to itsadvancement into the housing 212. Wings 218 at the end of the cartridgewill flex inward as the cartridge passes through the anvil extensionsabove the anvil pivot 220. Once they are past the anvil extensions, theyspring outward and when stapling forces are applied to drive staplesfrom the cartridge towards the anvil, the cartridge will slide backwardslightly and the wings will push on the anvil extensions above the anvilpivot. This will help to keep the anvil aligned with the cartridge face,even as stapling forces push them apart.

As best shown in FIG. 25, each cartridge includes a plurality of slots222 proportioned to receive a plurality of staples. Caps 224 arepositioned above the back spans of staples in the slots. Caps 224 areshown in only two of the slots 222 in FIG. 25. Each cap 224 includes asloped surface 226. During use, each of the four slots 222 may be filledwith staples and caps 224.

Referring to FIG. 26A, a driving wedge 232 has four wedge-shaped plates(only one of which is visible), each extending into one of the slots222. A cable pull or other mechanism is provided for advancing thedriving wedge longitudinally through the housing 210 (from left to rightin the illustrated drawings) so that the wedge-shaped plates movethrough the slots 222. The wedge-shaped plates are positioned such thatwhen they travel in the slots, they contact the caps 224 correspondingto the various staples S (FIGS. 26A-E) within a given slot 222 in amanner similar to that described in connection with FIGS. 9B-9E, therebydriving the staples into tissue positioned between the housing andanvil.

Spring 228 is disposed in a channel in the housing 212 and is configuredsuch that it is compressed as the driving wedge 232 is moved by the useractuating a cable or other force transfer element. For example, thewedge 232 might be coupled to a cable extending through the spring 228and attached to cap 234 on the spring 228 such that as the wedge movesto the right in FIG. 26A, the cable pulls the cap 234 to the left tocompress the spring. A second spring 230 is attached to the drivingwedge 232 and is compressed by a lever 236 riding in a groove 238 (FIG.25) in the cartridge. This groove 238 increases in depth at the end ofthe wedge's stroke, thus providing a notch 240 for the lever 236 to fallinto at the end of its travel.

FIG. 26A shows the staple head 210 after staples have been fired fromcartridge 216 b and after cartridge 216 a has been moved into thehousing such that its staples are in staple delivery positions ready forfiring. FIGS. 26A-26C show stages of staple deployment as the wedge 232is drawn over the staple driving elements or caps 234. The wedge 232moves from the home position (FIG. 26A) through the cartridge to deploythe staples through the tissue, such that their legs fold against theanvil 214. As the wedge advances, the spring 228 is compressed. As thewedge reaches the end of its travel, lever 236 pivots into the notch 240as shown in FIG. 26D. When the user stops pulling on the wedge (e.g. byreleasing a pull cable), the loaded return spring 228 will unload,driving the wedge 232 and lever 236 towards the home position, which istowards the left in the FIG. 26A-E drawings. The lever 236 pushesagainst wall 242 of the groove 238, thus driving the spent cartridge 216a out of the stapler (FIG. 26E) while drawing in the next loadedcartridge 216 b that is coupled to the cartridge 216 a.

The stapler is repositioned and the sequence is repeated until all thecartridges have been fired, or until stapling is complete.

It may be advantageous to maintain a level of mechanical simplicitycomparable to currently produced linear staplers, but enable multi-firecapability without the need to withdraw the stapler from the patient. Inthis design, the spent cartridge is made to be ejected and be dropped inplace, or be tethered or otherwise connected to the stapler or to thenext cartridge to be loaded into the stapler. Loading would beaccomplished with tools already in the patient, or with additionalmechanisms within the tool itself, which would form or act as a conveyorof, or conduit for, new cartridges being advanced to the stapler head.

The above groupings are not exclusive and, for example, radial driver ormagazine motion could be combined with stacked, flat nested, or chainedstaple arrangements.

It should be recognized that a number of variations of theabove-identified embodiments will be obvious to one of ordinary skill inthe art in view of the foregoing description. Moreover, features of thedisclosed embodiments may be combined with one another and with otherfeatures (including those taught in the prior applications referencedherein) in varying ways to produce additional embodiments. Accordingly,the invention is not to be limited by those specific embodiments andmethods of the present invention shown and described herein. Theapplications and methods listed are not limited to the treatment ofdiseases or procedures listed. Modifications of the above describedmethods and tools and variations of this invention that are obvious tothose of skill in the art are intended to be within the scope of thisdisclosure.

Any and all patents, patent applications and printed publicationsreferred to above, including those relied upon for purposes of priority,are incorporated herein by reference.

We claim:
 1. A stapler, comprising: a staple member including aplurality of staples; an anvil spaced from the staple member along anaxis, the staple member and the anvil configured to relatively movetowards and away from each other along the axis, wherein the pluralityof staples are oriented radially with respect to the axis; and a stapledriver configured to drive a first set of staples of the plurality ofstaples from the staple member towards the anvil, wherein the first setof staples (a) includes multiple staples equally spaced from the axis,and (b) includes less staples than the plurality of staples.
 2. Thestapler of claim 1, wherein the multiple staples of the first set ofstaples are symmetrically arranged about the axis.
 3. The stapler ofclaim 1, wherein the plurality of staples are symmetrically arrangedabout the axis.
 4. The stapler of claim 1, further including a pluralityof links that couple the staple member and the anvil, the plurality oflinks being configured to relatively move the staple member and theanvil towards and away from each other.
 5. The stapler of claim 4,wherein the plurality of links include one or more arm assemblies,wherein each arm assembly of the one or more arm assemblies includes aproximal section pivotally coupled to the staple member and a distalsection pivotally coupled to the anvil, wherein the proximal section andthe distal section are pivotally joined together at a hinge, such thatmovement of the staple member and the anvil towards each other causesthe proximal section and the distal section of the arm assembly to pivotoutwardly away from the axis.
 6. The stapler of claim 1, furtherincluding a vacuum chamber configured to acquire and position tissuebetween the staple member and the anvil.
 7. The stapler of claim 1,wherein the staple driver is configured to move in a direction generallyparallel to the axis to drive the first set of staples from the staplemember.
 8. The stapler of claim 1, wherein the staple driver is furtherconfigured to drive a second set of staples of the plurality of staplesfrom the staple member towards the anvil, wherein the second set ofstaples are (c) equally spaced from the axis, and (d) equal in number tothe first set of staples.
 9. The stapler of claim 8, wherein one of thestaple driver or the staple member is configured to rotate about theaxis after driving the first set of staples to align the second set ofstaples with the staple driver.
 10. The stapler of claim 8, wherein thestaple driver is further configured to drive a third set of staples ofthe plurality of staples from the staple member towards the anvil,wherein the third set of staples are (c) equally spaced from the axis,and (d) equal in number to each of the first set of staples and thesecond set of staples.
 11. A stapler, comprising: an elongate shafthaving a distal end, and a stapler head positioned at the distal end ofthe elongate shaft, the stapler head including: an anvil; a staplemember spaced from the anvil along an axis, the staple member includinga plurality of staples arranged symmetrically about the axis andoriented radially with respect to the axis; and a staple driverconfigured to simultaneously drive each staple of a first set of staplesof the plurality of staples from the staple member towards the anvil,wherein the first set of staples (a) are equally spaced from the axis,and (b) includes less staples than the plurality of staples.
 12. Thestapler of claim 11, further including one or more arm assemblies thatcouple the staple member and the anvil together, wherein each armassembly of the one or more arm assemblies includes a proximal sectionpivotally coupled to the staple member and a distal section pivotallycoupled to the anvil, wherein the proximal section and the distalsection are pivotally joined together at a hinge, such that movement ofthe staple member and the anvil towards each other causes the proximalsection and the distal section of the arm assembly to pivot outwardlyaway from the axis.
 13. The stapler of claim 11, wherein the stapledriver is configured to move in a direction generally parallel to theaxis to drive the first set of staples from the staple member.
 14. Thestapler of claim 11, wherein the staple driver is further configured todrive a second set of staples of the plurality of staples from thestaple member towards the anvil, wherein the second set of staples are(c) equally spaced from the axis, and (d) equal in number to the firstset of staples.
 15. The stapler of claim 14, wherein at least one of thestaple driver and the staple member is configured to rotate about theaxis after driving the first set of staples to align the second set ofstaples with the staple driver.
 16. The stapler of claim 14, wherein thestaple driver is further configured to drive a third set of staples ofthe plurality of staples from the staple member towards the anvil,wherein the third set of staples are (c) equally spaced from the axis,and (d) equal in number to each of the first set of staples and thesecond set of staples.
 17. A stapler, comprising: an anvil; a staplemember spaced from the anvil along an axis, the staple member includinga plurality of staples oriented radially with respect to the axis, theplurality of staples including at least a first set of staples and asecond set of staples; and a staple driver configured to (i) drive thefirst set of staples from the staple member towards the anvil at a firsttime, and (ii) drive the second set of staples from the staple membertowards the anvil at a second time, wherein each of the first set ofstaples and the second set of staples includes two or more staplessymmetrically arranged about the axis, and the first set of staples andthe second set of staples include an equal number of staples.
 18. Thestapler of claim 17, further including one or more arm assemblies thatcouple the staple member and the anvil together, wherein each armassembly of the one or more arm assemblies includes a proximal sectionpivotally coupled to the staple member and a distal section pivotallycoupled to the anvil, wherein the proximal section and the distalsection are pivotally joined together at a hinge, such that movement ofthe staple member and the anvil towards each other causes the proximalsection and the distal section of the arm assembly to pivot outwardlyaway from the axis.
 19. The stapler of claim 17, wherein at least one ofthe staple driver and the staple member is configured to rotate aboutthe axis after driving the first set of staples to align the second setof staples with the staple driver.
 20. The stapler of claim 17, whereinthe staple driver is further configured to drive a third set of staplesof the plurality of staples from the staple member towards the anvil,wherein the third set of staples are (c) symmetrically arranged aboutthe axis, and (d) equal in number to each of the first set and thesecond set of staples.